The Biosimilar Race: APAC's Factory to the World Confronts the Value Trap
核心洞察
The global biosimilar market expanded fifteen-fold from US$2.2 billion in 2016 to roughly US$32.7 billion in 2024, with Korea and India serving as its manufacturing engine room.
Despite record revenues at Celltrion, Samsung Bioepis (搜索), and Biocon, APAC manufacturers face a structural "value trap" where US pharmacy benefit managers capture the economic upside through private-label biosimilars.
The FDA is dismantling interchangeability requirements, proposing to eliminate comparative clinical efficacy studies, which simultaneously lowers development costs and erodes product differentiation.
In Songdo and Bengaluru, the numbers finally look like the ones the region was promised a decade ago. Celltrion closed 2025 with revenue above ₩4 trillion — roughly US$2.8 billion — and operating profit past the ₩1 trillion mark, paying staff bonuses worth close to half a year's salary. Samsung Bioepis (搜索) booked a record first quarter, with operating profit up 236 percent year on year and an operating margin north of 30 percent. Biocon's biosimilars arm ran four separate products past US$200 million in annual sales inside a single fiscal year.
These are not the margins of a commodity business. They represent the vindication of a twenty-year bet: that Asia could take the most technically demanding class of medicines ever commercialised — large-molecule biologics, grown in living cells, impossible to copy atom-for-atom — and manufacture them at a quality and scale the West would have to buy from. And yet the people running these companies are unusually anxious for an industry printing record profit.
The biologics losing exclusivity between now and the mid-2030s represent one of the largest transfers of pharmaceutical value in history. APAC is positioned to manufacture an enormous share of the copies. It is positioned to capture very little of the value. The originator economics — the pricing power, the formulary leverage, the brand — mostly stay somewhere else.
The Scale: A Workshop Fully Built
The global biosimilar market grew from about US$2.2 billion in 2016 to roughly US$32.7 billion in 2024 — a fifteen-fold expansion in eight years, driven by patent expiries and relentless payer pressure to cut drug spending. Korea and India are not participants in that market so much as its engine room.
Celltrion won approval for the world's first monoclonal-antibody biosimilar, Remsima, back in 2013, and now runs an integrated model spanning development, manufacturing and direct global sales. Samsung Bioepis (搜索) has launched eleven biosimilars since 2012 and, together with Celltrion, controls more than half of six major biosimilar categories in Europe. Samsung Biologics, the contract-manufacturing sibling, is building toward 1.32 million litres of bioreactor capacity by 2032 — a scale that would make it comfortably the largest biomanufacturer on earth.
India's contribution runs on a different but complementary logic. Biocon Biologics (搜索) has commercialised ten biosimilars with a pipeline of more than twenty assets across diabetes (搜索), oncology, immunology, ophthalmology and bone health, and holds roughly a fifth of the US insulin glargine market. Where Korea tends to compete on antibody sophistication and integrated scale, India competes on cost base, process economics and a deep bench of exporters — Biocon, Dr Reddy's (搜索), Cipla, Zydus — that can flood price-sensitive markets fast.
Behind them sits the reason this all matters right now: the wave. Drugs set to lose patent protection between 2025 and 2030 carried combined 2024 sales of about US$127.6 billion. Samsung Bioepis (搜索)'s own tracking puts it more starkly still — some 118 biologics representing close to US$232 billion in US sales are due to lose exclusivity between 2025 and 2034. Ustekinumab (Stelara) has already gone. Aflibercept (Eylea), denosumab, golimumab and a long tail of oncology and immunology antibodies are going now. The GLP-1 (搜索) franchises — the biggest prize in modern pharma — are beginning to crack open at the edges.
The Value Trap: Making Everything, Keeping Little
Consider Stelara, the defining biosimilar launch of 2025 and a preview of every launch to come. Within months of exclusivity ending, the US market held nine biosimilar versions of ustekinumab plus an unbranded biologic sold by the originator itself — with list-price discounts running anywhere from 5 to 90 percent off a reference product that had carried a wholesale acquisition cost near US$30,000 per 90mg dose. One mid-sized pharmacy benefit manager projected US$120 million in annual savings from swapping Stelara for biosimilars, on top of the US$100 million-plus it had already banked by dropping Humira the year before.
But the picture darkens when examining who captured the upside. The three PBMs that dominate US drug purchasing — Caremark, Express Scripts and Optum Rx — did not simply add the cheapest biosimilar to their formularies. They launched their own private-label versions through affiliated subsidiaries and gave those preferred placement, in several cases while keeping the expensive reference product on formulary too because the rebate maths favoured it. The company that spent five to seven years and US$100 million to US$300 million developing a Stelara biosimilar frequently found itself supplying a molecule that a PBM re-badged, priced and controlled.
That last figure dismantles the lazy assumption that biosimilars are "just generics." A small-molecule generic can be reverse-engineered in a year for a few million dollars. A biosimilar takes the better part of a decade and a nine-figure budget — the risk profile of a mid-stage novel drug — and then lands into a market that pays it like a commodity. The developer carries the cost structure of an innovator and the pricing power of a contract manufacturer.
Layer on the policy machinery and the squeeze tightens further. Stelara was among the first drugs subject to US Medicare price negotiation under the Inflation Reduction Act, with a 2026 maximum fair price set roughly 66 percent below its 2023 list. Negotiated originator prices compress the ceiling that biosimilars price beneath, thinning already-thin margins from the top down even as private labels attack from below.
And then there is the cruel irony buried in the wave itself. Of those 118 biologics worth US$232 billion heading off-patent through 2034, only around 10 percent have a biosimilar in active development. The industry calls this the "biosimilar void" — and it is a direct consequence of the value trap. The workshop is fully capable of making these products. It is increasingly choosing not to, because it cannot see how to make money doing so.
Interchangeability: The Ground Shifts Under Everyone
Into this pressure cooker, the US regulator has thrown a genuine wildcard — one that cuts in two directions at once. For a decade, the US operated a two-tier system found nowhere else: an ordinary "biosimilar," and a more rigorously vetted "interchangeable" biosimilar that a pharmacist could substitute for the brand without calling the prescriber. Interchangeability required expensive clinical switching studies, and it functioned as a marketing moat.
That system is being dismantled in real time. A June 2024 draft guidance signalled that switching studies would generally no longer be needed. Then, in October 2025, the FDA went further, proposing that comparative clinical efficacy studies — long the single most expensive element of a biosimilar programme — may not be necessary at all, with high-quality analytical characterisation plus pharmacokinetic and immunogenicity data doing the work instead. The agency signalled it intends to finalise the framework in early 2026 and may begin approving all non-vaccine biosimilars as interchangeable by default. Approval timelines had already compressed sharply — from an average of around 798 days for applications filed in 2020 to roughly 364 days for those filed in 2024.
For a manufacturer, this is a double-edged blade. The upside is real: eliminating comparative efficacy trials could strip US$100 million-plus and years out of a development programme. Korea's own regulator is moving in parallel, relaxing Phase 3 requirements, and Celltrion has been publicly revising trial plans to match — its chairman, Seo Jung-jin, welcomed the shift as "big news we have waited for over a long period of time." The downside is just as real: every barrier the regulator removes is a barrier that protected incumbents' margins. If interchangeability becomes automatic and clinical trials become optional, the last few sources of differentiation between biosimilars evaporate — leaving price, supply reliability and payer relationships, exactly the axes on which vertically-integrated Western PBMs already hold the whip hand.
The GLP-1 (搜索) Race: The Whole Thesis, Compressed
Nowhere will the region's dilemma be tested more visibly than in GLP-1s — the obesity (搜索) and diabetes (搜索) franchises that have become the most valuable drugs on the planet.
Liraglutide has already gone generic: Teva (搜索) launched in the US in August 2025, and Biocon won FDA approval for its version in February 2026, covering both diabetes (搜索) and weight management. But early savings are modest, because a first-generation drug competing against vastly more effective successors has limited pricing leverage.
Semaglutide — the Ozempic and Wegovy molecule where the real money sits — is where geography becomes destiny. In the US, the picture is a fortress: the core compound patent's nominal March 2026 expiry has been extended to December 2031, behind a thicket of 49 follow-on patents on formulation and delivery devices stretching toward 2042. In India, the patent office rejected Novo Nordisk's semaglutide claim back in 2019 as an obvious modification of liraglutide, meaning Indian manufacturers can produce it now. The molecule loses protection across India and China in 2026.
This hands APAC a genuine first-mover window — but pointedly not in the market that pays the most. Indian firms including Biocon, Cipla and Dr Reddy's (搜索) are targeting domestic launches in late 2026 and export markets in 2027–2028; Biocon has already partnered with Biomm to commercialise an off-patent candidate in Brazil, and Samsung Bioepis (搜索) has a liraglutide biosimilar in Phase 3. Analysts expect prices to fall by up to 70 percent in developing markets. Meanwhile, Novo Nordisk launched oral semaglutide in early 2026; Eli Lilly won approval for the oral GLP-1 (搜索) orforglipron in April 2026; tirzepatide is locked up until 2036.
The Move Upmarket: The Only Exit That Matters
The most revealing corporate action of the past year was not a product launch but a restructuring. In November 2025, Samsung split its biosimilar arm into a new holding company, Samsung Epis Holdings, explicitly charged with developing platform technologies and novel drug candidates — while Samsung Biologics doubled down as a pure-play contract manufacturer. That is a company formally separating the low-margin factory from the aspiration to invent.
Celltrion is making the same bet through vertical integration — internalising R&D and manufacturing, moving to direct commercialisation to capture the margin that partners used to take, and expanding its US manufacturing footprint through acquisition. Biocon's version runs through insulins and increasingly complex biologics, funded by a January 2026 capital raise to buy out its former partner's minority stake. Every serious player has arrived, independently, at the same conclusion: biosimilars are the tuition, not the degree.
But none of them has yet made the leap, and the leap is genuinely hard. Novel biologics require discovery capability, clinical-development muscle, first-in-class regulatory experience, and — hardest of all — the appetite to absorb the failure rate of real innovation. The biosimilar business builds excellence in precisely the capabilities that matter least for the leap ahead — manufacturing, quality systems, regulatory execution — while offering no training at all in the one that matters most: the willingness to take a scientific bet that may simply fail.
The machinery is built. The wave has arrived. What APAC does with the next five years — not the manufacturing, which is settled, but the climb toward invention, which is not — will decide whether the region remains the indispensable, brilliant, low-margin factory inside a value chain whose economics are decided in Boston, Basel and the formulary committees of three American PBMs, or whether it finally becomes an originator defending its own blockbusters.